MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problem Low Readings (2460)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A 13 month lot-serial number history review for similar complaints was performed for column serial number (b)(4) from 17nov2017 through aware date (b)(4) 2018.There were no similar complaints identified during the search period.The g8 operator's manual chapter 1: introduction and applications & chapter 4 screen operations & chapter 6, troubleshooting, state the following: 6.3 error messages: when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages: with these errors, the assay stops and the analyzer immediately enters stand-by state.211 peak pattern error: explanation: peaks were not separated well.Countermeasure: check the samples, buffers, and hemolysis & wash solution.6.4 abnormal chromatograms: chromatograms from patients with hemoglobin variants or unknown peaks not recognized by the analyzer are occasionally seen during routine testing.These patterns may indicate interferences or problems with the assay.Therefore, it is important to use caution when troubleshooting.Review all chromatograms to determine whether the results are valid.Chapter 1: introduction and applications: the time from injection of the sample to the time the specific peak elutes off the column is called retention time.The tosoh automated glycohemoglobin analyzer hlc-723g8 software has been written so that each of the expected fractions has a window of acceptable retention times.If the designated peak falls within the expected window, the chromatogram peaks will be properly identified.When a peak elutes at a retention time not within a specified window, an unknown peak (p00) results.If more than one peak elutes at times not specified by the software windows, each is given a sequential p0x title.In order to keep the peaks within their appropriate windows, it may be necessary to change how fast or slow the buffers are moving through the system by changing the pump flow rate.The most probable cause of the reported event was due to flow rate adjustment required.

Event Description

The customer reported that they received intermittent low and discrepant results with their g8 analyzer.One hba1c patient sample result was 2.2% with a p00 peak, and retention time (rt) 0.57 minutes (range 0.57-0.62).The customer did have normal patient samples and reported that one of those was 7.1%.Prior to calling technical support the customer attempted to troubleshoot by changing the filter.The column count was reported to be 1896 injections, buffer volumes on 1, 2 and 3 were half full, and hemolysis wash had been changed that morning.Device pressure was noted to be 8.6 megapascals (mpa) and total areas were all within range (500-4500).Technical support instructed the customer to check for leaks at the filter or column and to confirm that buffer and column were the n lot numbers.Next, ts instructed the customer to adjust the flow rate from 1.05 to 1.03 minutes to increase rt.The customer reran the same samples and the rt was now 0.64 on both reruns.The low patient result (2.2%) had increased to 5.9% and had no p00 peak and the normal patient sample was now 7.4%.The customer performed a drain flush, and then adjusted the flow rate once more to 1.07.Rt was now 0.62.Ts, again, advised the customer to rerun quality control (qc) and the two samples.Qc was now within range and the two samples results were 5.9% and 7.2%, respectively.Lastly, the customer checked 25% of the samples that had run and noted that they varied by 2% or less.No further issues were noted.No further action was required by technical support.There was no indication of any patient intervention or adverse health consequences due to the reported event.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 105-8 623; JA 105-8623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco,
• MDR Report Key: 8215011
• MDR Text Key: 133389169
• Report Number: 8031673-2018-05408
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2018
• Distributor Facility Aware Date: 12/17/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/03/2018
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1